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An overview of a case of SLK treated with complete ocular lavage facilitated by an irrigating eyelid retractor.

Case report: Superior limbic keratoconjunctivitis

The FDA has granted Breakthrough Device designation for SightGlass Vision's Diffusion Optics Technology (DOT) spectacles lenses, which are under investigation for the slowing of myopia in children.

 DOT is the first design to leverage contrast management mechanism of action, which gently scatters light across the retina. If approved by the FDA, DOT spectacle lenses will be the first non-contact lens myopia control tactic available to the US market.

“The FDA Breakthrough Device designation for Diffusion Optics Technology (DOT) spectacle lenses is a milestone for our organization—and for the broader fight against the pediatric myopia epidemic. Recent studies

 illustrate that about half of U.S. children are myopic, yet most are not receiving treatments proven to slow myopia progression,” Andrew Sedgwick, CEO of SightGlass Vision, said in a press release. “We are enthusiastic about more closely collaborating with the FDA as we pursue US market clearance.”

DOT technology has a rich history of positive results in clinical trials. The CYPRESS study is in its 5th year, with the most recent data presented in September 2023 at the Congress of the Chinese Ophthalmological Society in Changsha.

 The full 4-year outcomes showed statistically significant slowing of axial length progression and cycloplegic spherical equivalent refraction (cSER) in patients aged 6-10 who used DOT spectacle lenses.

Prior to this, SightGlass Vision presented positive outcomes at ARVO 2023 in New Orleans, Louisiana. The 42-month data from the CYPRESS study extension indicated positive safety and efficacy in children aged 6-10 (at the start of the study).

 The extension re-enrolled 98 patients from the original multi-site clinical trial, which had previously reported improvements in axial length and cSER.

SightGlass Vision, which is a joint venture of CooperCompanies and EssilorLuxottica, has set its sights on developing innovative technologies to combat the global myopia crisis. DOT spectacle lenses are already on the market in China, the Netherlands, and Israel, and the technology is in preliminary market trials in other countries.

1. SightGlass Vision receives breakthrough device designation from US Food and Drug Administration. Press release. February 14, 2024. Accessed February 15, 2024.

Current Trends in Pediatric Eye Examinations and Contact Lens Prescribing in the U.S.

 Poster presentation at the Global Specialty Lens Symposium, January 2024.

3. Myopia Management 2024 Report, Jobson Optical Research, January 2024. 

https://reviewofmm.com/2024-myopia-report/

4. SightGlass presents four-year results of CYPRESS trial at CCOS. Review of Myopia Management. September 5, 2023. Accessed February 15, 2024. https://reviewofmm.com/sightglass-presents-four-year-results-of-cypress-trial-at-ccos/

5. Chalberg T, et al. Control of myopia using diffusion optics spectacle lenses: efficacy and safety study (CYPRESS) 42-month results. ARVO 2023 Annual Meeting presentation. 27 April 2023.

Diffusion Optics Technology (DOT) spectacle lenses are intended to slow myopia progression in children via contrast management mechanism of action.

Pipeline

FDA grants SightGlass Vision Breakthrough Device designation for DOT spectacle lenses

Patient Case 2: Reversal of Contact Lens Intolerance in a Young Patient Following Demodex Blepharitis Treatment

A panelist discusses how treating Demodex blepharitis led to successful reversal of contact lens intolerance in a young patient, highlighting the importance of addressing underlying ocular surface conditions.

Video Series

Patient Case 1: Delaying Cataract Surgery to Prioritize Aggressive Treatment of Ocular Surface Disease, Including Demodex Blepharitis

A panelist discusses how prioritizing aggressive treatment of ocular surface disease, particularly Demodex blepharitis, before proceeding with cataract surgery can lead to better surgical outcomes and patient satisfaction.

Preoperative Ocular Surface Disease Algorithm Overview

A panelist discusses how evaluating and treating ocular surface disease before cataract or refractive surgery through a systematic algorithm improves surgical outcomes and patient satisfaction.

This poll is for optometrists and eyecare professionals, only. It will close on Friday, November 5, 2021.

Poll: What pipeline presbyopia treatment are you most looking forward to?

-In the midst of its contentious merger offer from Novartis, Alcon Inc. announced it will acquire the rights to three products from Tampa, FL-based Sirion Therapeutics Inc. 

On Jan. 18, Alcon said it would acquire the U.S. rights to two FDA-approved products-difluprednate ophthalmic emulsion (Durezol) 0.05%, an ophthalmic corticosteroid in drop form for the treatment of inflammation and pain associated with eye surgery, and ganciclovir ophthalmic gel 0.15% (Zirgan), which the FDA approved on Sept. 17 for treating acute herpetic keratitis. In April 2007, the FDA had granted the gel orphan drug status. 

The acquisition also gives Alcon nearly global rights, excluding Latin America, to cyclosporine (Zyclorin), an investigational drug being developed to treat dry eye and other ocular surface diseases. The deal is expected to close by the end of Q1 2010, and hinges on customary closing conditions and required regulatory approvals. 

"While the potential Novartis deal is certainly an issue for us, our leadership is focused more on continuing to build Alcon's commercial capabilities and research pipeline," MacHatton said. "The Sirion deal is a good example of that, as it brings a currently marketed product in Durezol, the recently approved orphan drug Zirgan that will be launched soon, and a potential dry-eye treatment for our pipeline." 

MacHatton declined to say the cost of the acquisitions. 

Sirion spokeswoman Erin Parsons said the deal is "totally separate" from Alcon's discussions with Novartis. "We are certain this will not affect the completion of the deal between Alcon and Sirion," she said. 

In the midst of the contentious merger offer from Novartis, Alcon Inc. announced it will acquire the rights to three products from Tampa, FL.-based Sirion Therapeutics Inc.

Gillian Barach, BS

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